NCT02129881|CompletedPhase 1/2DMC
The ONE Study UK Treg Trial
ONETreg1
The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
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Sponsor study identifier
interventional
15
1 country
2
Study Start
April 2014
Actual (reported)Primary Completion
March 23, 2017
Actual (reported)Study Completion
March 23, 2017
Actual (reported)A study to assess cell therapy as a treatment to prevent kidney transplant rejection. The trial will involve purification of naturally occurring regulatory T cells (nTregs) from living-donor renal transplant recipients. The cells will then be grown in the laboratory and re-infused into the patient five days after the kidney transplant. This trial is part of an international European Union funded consortium aimed at evaluating cellular immunotherapy in solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced by nTreg therapy can eventually be used to recude the need for conventional immunosuppression in transplant recipients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 23, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2014
Actual (reported)May 1, 2014
Actual (reported)May 2, 2014
Actual (reported)March 23, 2017
Actual (reported)March 23, 2017
Actual (reported)Incidence of biopsy-confirmed acute rejection.
60 weeks
Time to first acute rejection episode
60 weeks
Severity of acute rejection episodes
60 weeks
Total immunosuppressive burden
60 weeks
Incidence of chronic graft dysfunction
60 weeks
Incidence of graft loss through rejection
60 weeks
Autologous regulatory T Cell Product (1-10 million cells/kg) infused intravenously 5 days post renal transplantation. Recipients also receive prednisolone, mycophenolate mofetil, and tacrolimus as detailed below: Prednisolone Day 0: 500 mg IV (250mg pre-op, 250mg intra-op) Day 1: 125 mg IV Day 2 to 14: 20.0 mg/day oral Week 3 to 4: 15.0 mg/day oral Week 5 to 8: 10.0 mg/day oral Week 9 to 12: 5.0 mg/day oral Week 13 to 14: 2.5 mg/day oral Week 15 to End: Cessation Mycophenolate Mofetil (MMF) Day -7 to -2: 500 mg/day oral Day -1 to 14: 2000 mg/day oral Week 3 to 36: 1000 mg/day oral Week 37 to 40: 750 mg/day oral Week 41 to 44: 500 mg/day oral Week 45 to 48: 250 mg/day oral Week 49 to End: Cessation Tacrolimus Day -4 to 14: 3-12 ng/ml oral Week 3 to 12: 3-10 ng/ml oral Week 13 to 36: 3-8 ng/ml oral Week 37 to End: 3-6 ng/ml oral
Autologous regulatory T Cell Product (1-10 million cells/kg) infused intravenously 5 days post renal transplantation. Recipients also receive prednisolone, mycophenolate mofetil, and tacrolimus as detailed in the arm description.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Guy's Hospital
London, SE1 9RT, United Kingdom
The Oxford Transplant Centre - Churchill Hospital
Oxford, OX3 7LE, United Kingdom
McCallion O, Cross AR, Brook MO, Hennessy C, Ferreira R, Trzupek D, Mulley WR, Kumar S, Soares M, Roberts IS, Friend PJ, Lombardi G, Wood KJ, Harden PN, Hester J, Issa F. Regulatory T cell therapy is associated with distinct immune regulatory lymphocytic infiltrates in kidney transplants. Med. 2025 May 9;6(5):100561. doi: 10.1016/j.medj.2024.11.014. Epub 2024 Dec 27.
Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Boger CA, Scotta C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Ollinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyo J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7.
Giovanna Lombardi, PhD
King's College Hospital NHS Trust
15 participants (actual enrollment reported by the registry).
First Submitted
May 1, 2014
First Posted
May 2, 2014
Study Start
April 2014
Actual (reported)Primary Completion
Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation
Contact the study team to confirm eligibility.
March 23, 2017
Actual (reported)Study Completion
March 23, 2017
Actual (reported)Last Updated
January 25, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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